BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 COCR LFIT HEAD 36MM/+10

    MDR report key: 1890695 · Received November 1, 2010

    Report

    Report Number
    2249697-2010-01444
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "OPENED PACKAGE FOR THIS HEAD AND THE PLASTIC WAS CRACKED, SO COMPROMISED INNER STERILE BARRIER. HAD ANOTHER SET, AND USED A DIFFERENT HEAD, SAME SIZE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/+10 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MHT8KA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention